24th April 2018
As previously disclosed, in July 2017, Kamada submitted a proposed Phase 3 study protocol for Inhaled AAT for treatment of AATD to the FDA. In response, in August 2017, the FDA issued a letter to the Company stating the agency’s continued concerns and questions regarding the safety and efficacy of Inhaled AAT for the treatment of AATD and the risk/benefit balance to patients. In March 2018, following further discussions and based on additional feedback received from the FDA, Kamada submitted a revised pivotal Phase 3 protocol to the FDA, as well as additional information related to the FDA questions and concerns.
In response to the revised study protocol and the information provided by the Company, in April 2018, the FDA issued a response letter providing further guidance regarding the proposed pivotal Phase 3 protocol, as well as additional questions focused on the Inhaled AAT product characteristics. This correspondence indicated that, while several issues had been addressed, the FDA has continued concerns and questions related to the safety profile of Inhaled AAT.
Following a thorough assessment of the FDA response, Kamada intends to provide the requested information and data, as well as implement the proposed changes in the study protocol, during the third quarter of 2018. The Company anticipates that its planned response will result in continued interaction with the FDA. The proposed modifications and additional information to be provided, are intended to mitigate the continued safety-related concerns communicated by the FDA.
Although the Company previously stated its intent to initiate the Phase 3 clinical study of Inhaled AAT for treatment of AATD in the second half of 2018, it will not be able to do so, until such time when communication with the FDA will be concluded to the FDA’s satisfaction, and the Company’s Investigational New Drug Application (IND) is approved. The Company cannot currently anticipate if and when these discussions with the FDA will materialize into an approved IND.
In parallel with the continued discussions with the FDA, the Company has formally requested, and is expecting to present its planned Phase 3 protocol in a Scientific Advice meeting with the European Medicines Agency in the third quarter of 2018, in order to obtain feedback and guidance in connection to the regulatory path for Inhaled AAT in Europe.
You can see the full story here: https://globenewswire.com/news-release/2018/04/23/1485248/0/en/Kamada-Received-Feedback-from-FDA-on-Proposed-Phase-3-Protocol-for-Inhaled-Alpha-1-Antitrypsin-for-Treatment-of-Alpha-1-Antitrypsin-Deficiency-Disease.html